FDA.reportPublic FDA data

AOS CORTICAL SCREW 3.5mm x 14.0mm

Primary DI
00848665007251
Brand
AOS CORTICAL SCREW 3.5mm x 14.0mm
Company
ADVANCED ORTHOPEDIC SOLUTIONS INC
Model
S8010-140
Published
2016-01-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848665007251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665007251008486650072518486650072510848665007251

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117858154
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848665027679COUNTERSINK4006-0002020-06-15
00848665000658AOS Drill, AO Style, 2.9mm x 100mm02242020-05-20
00848665001235AOS CANCELLOUS TAP 3.5mm02552020-05-21
00848665027624SUPRAPATELLAR TIBIAL ENTRY SHEATH06422020-05-20
00848665028041T10 Screwdriver, Short50252020-05-20
008486650280963.5mm Calibrated Drill40252020-05-20
00848665028119AOS 2.6mm Solid Reamer40212020-05-20
00848665028782T10 Screwdriver, Solid50202020-05-20
00848665028850AOS SMALL BONE REAMER Ø3.1 x 328mm4020-0312020-05-20
00848665028867AOS SMALL BONE REAMER Ø3.7 x 328mm4020-0372020-05-20
00848665028874AOS SMALL BONE REAMER Ø4.1 x 328mm4020-0412020-05-21
00848665028881AOS SMALL BONE REAMER Ø5.1 x 328mm4020-0512020-05-20
00848665028935Calibrated Drill, AO Style, 2.5mm x 200mm40162020-05-20
00848665028942Calibrated Drill, AO Style, 2.0mm x 200mm40172020-05-20
008486650292152.7mm Calibrated Drill40262020-05-20
008486650300374.0mm CORTICAL TAP (AO STYLE)40292020-05-21
00848665030051AOS T10 SCREWDRIVER, AO STYLE5008-1002020-05-21
00848665030075AOS Cannulated Drill, 2.75mm, Ankle Plate4010-1002020-05-20
00848665030099AOS DRILL, Ø2.8mm4009-1002020-05-20
00848665030105QUICK DRILL, Ø1.9mm40282020-05-20

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Primary DI, Brand, Company table
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00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16